(92 days)
The OneQ-SL s-Clean Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.
The OneQ-SL s-Clean Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. This implant system has internal hex connection, tapered with straight body, bone level and submerged type that are similar to other commercial available products based on the intended use, technology used, the claims, the material composition employed and performance characteristics. This implant system is supplied sterile. The OneQ-SL s-Clean Implant system is substantially equivalent in connection structure, similar design, function and intended use to the predicate device, OneQ-SL s-Clean Implant System (K153639). This subject device is compatible with the abutments of K073486, K082843, K111364 and K150344. The fixture is made of Ti-6A1-4V ELI and Pure Titanium Grade 4. The Cover screw was cleared in K073486. The surface is treated by Sand -blasting (Large grit) and acid etching method (SLA). This system only contains the implant bodies with cover screw and are provided as set-packing. The purpose of this submission is to add new fixtures.
This appears to be a 510(k) premarket notification for a medical device, specifically an endosseous dental implant system. The document states that the device, "OneQ-SL s-Clean Implant System," is substantially equivalent to legally marketed predicate devices, and therefore no new clinical studies are presented within this document to prove acceptance criteria through device performance.
The document does not describe acceptance criteria for a new device's performance through a clinical or non-clinical study directly comparing it to defined metrics. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices based on technological features, materials, and existing non-clinical test data.
Therefore, many of the requested elements about acceptance criteria and device performance based on a new study (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment for a new training set) are not applicable or available in this kind of regulatory submission. The "acceptance criteria" here is primarily about meeting the requirements for substantial equivalence to a predicate device.
Let's break down what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
This document doesn't provide a table of acceptance criteria and reported device performance for the new device that would typically come from a specific study designed to show such performance. Instead, it leverages test results from predicate devices and applies them to the current device to demonstrate substantial equivalence.
The acceptance criteria here would implicitly be that the subject device's performance in mechanical properties, sterilization, biocompatibility, and shelf life is equivalent to or better than the predicate devices, as demonstrated by meeting established standards.
| Acceptance Criteria (Implied) | Reported (Leveraged) Device Performance |
|---|---|
| For Sterilization: | Gamma Sterilization Validation Test (according to ISO11137-1,-2): Tests performed for predicate devices (K153639, K161244) were leveraged. The results "met the standards, and demonstrated the substantial equivalence with the predicate device." |
| For Shelf Life: | Shelf Life Validation Tests (referenced in K153639 and K161244): |
| - Tensile Strength (according to ASTM D882) | - Results "met the standards, and demonstrated the substantial equivalence." |
| - Seal Peeling (according to ASTM F88) | - Results "met the standards, and demonstrated the substantial equivalence." |
| - Burst Test (according to ASTM F1140) | - Results "met the standards, and demonstrated the substantial equivalence." |
| - Dye Penetration (according to ASTM F1929) | - Results "met the standards, and demonstrated the substantial equivalence." |
| - Bubble Test (according to ASTM F2096) | - Results "met the standards, and demonstrated the substantial equivalence." |
| For Mechanical Fatigue: | Fatigue Test (according to ISO 14801:2007): Tests performed for predicate devices (K150344, K153639) were leveraged. The results "met the standards, and demonstrated the substantial equivalence." |
| For Biocompatibility: | Biocompatibility Test (referenced in K161244): |
| - Cytotoxicity (according to ISO10993-5) | - Results "met the standards, and demonstrated the substantial equivalence." |
| - Sensitization (according to ISO10993-10) | - Results "met the standards, and demonstrated the substantial equivalence." |
| - Irritation (according to ISO10993-10) | - Results "met the standards, and demonstrated the substantial equivalence." |
| - Acute systemic toxicity (according to ISO 10993-11) | - Results "met the standards, and demonstrated the substantial equivalence." |
| - Implantation (according to ISO 10993-6) | - Results "met the standards, and demonstrated the substantial equivalence." |
| - Genotoxicity (according to ISO 10993-3) | - Results "met the standards, and demonstrated the substantial equivalence." |
| - Subchronic Toxicity (according to ISO 10993-11 and ISO 10993-6) | - Results "met the standards, and demonstrated the substantial equivalence." |
| For Endotoxin: | Endotoxin Test (according to USP ): Tests performed for predicate device (K161244) were leveraged. The results "met the standards, and demonstrated the substantial equivalence." |
| For Substantial Equivalence of Design/Dimensions/Materials: | The subject device adds new fixtures (diameters Ø3.7, Ø3.9) made of Ti-6Al-4V ELI (in addition to Pure Titanium Grade 4). This is supported by comparison to predicate K161244 (s-Clean OneQ-SL Narrow Implant System, made of Ti-6Al-4V-ELI) and K153639 which had similar diameters. The shelf life of 8 years is supported by predicate K161244 (8 years). The overall design, function, intended use, and material composition are stated to be similar to and substantially equivalent to the primary predicate K153639. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test (e.g., number of implants tested for fatigue). The document indicates that "Below tests were performed for predicate devices and leveraged for the subject device."
- Data Provenance: The tests were performed for predicate devices (K153639, K161244, K150344). No information regarding the country of origin of the data is provided, nor whether it was retrospective or prospective. It is non-clinical lab testing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the document relies on non-clinical testing against recognized standards (ISO, ASTM, USP) for demonstrating substantial equivalence, not expert ground truth for a clinical dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable as there is no clinical test set requiring adjudication in this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. This is a submission for an endosseous dental implant, which is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable. This refers to AI/algorithm performance, which is not relevant for this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests, the "ground truth" or reference for acceptance is the specified performance criteria within the referenced international standards (ISO, ASTM, USP) which determine if the device (or its predicate) performed adequately.
8. The sample size for the training set:
This is not applicable as this is not a submission for an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for an AI/machine learning device.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.